Sterilizing cap for male and female connectors comprising constraining lock

Abstract

A cap configured to engage different types of connectors includes a housing having an open first end, a second end, a sidewall extending between the first end and the second end, and an opening extending through the sidewall. The cap also includes a flexible sleeve disposed in the housing, the flexible sleeve having a first end, a second end, and a sleeve sidewall extending between the first end and the second end. The cap further includes a lock connected to the housing configured to move through the opening of the housing to press against the sleeve sidewall, which causes the sleeve sidewall to press directly or indirectly against a portion of the connector to secure the connector in the housing; and an absorbent member disposed in the flexible sleeve configured to contain a cleaning solution for cleaning and / or disinfecting a portion of the connector engaged with the cap.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims priority to U.S. Invention Application No. 17 / 994,929, filed on November 28, 2022, titled "Disinfecting Cap for Male and Female Connectors Including a Constricting Lock", the entire disclosure of which is hereby incorporated by reference in its entirety. Technical Field

[0003] The present disclosure generally relates to caps for medical connectors. In particular, it relates to a medical cap configured to be attached to a male connector or a female connector for sealing, cleaning, and disinfecting a portion of the connector. Background Art

[0004] Vascular access devices (VADs) are commonly used medical devices, which may include intravenous (IV) catheters, such as peripheral catheters or central venous catheters. If not properly maintained or if exposed to a non - sterile environment, VADs can become contaminated, sealed with blood clots, and / or may transmit infections. In addition, bacteria and other microorganisms may enter the patient's vascular system from the access site, port, or valve when connected to a VAD to deliver fluids or medications to the patient. Thus, each access site, port, valve, or other connector configured to be attached to a VAD is associated with some risk of transmitting catheter - related bloodstream infections (CRBSIs) to the patient.

[0005] Many healthcare facilities implement aseptic practices and protocols to ensure that VADs and access sites or ports are used correctly and are not sealed or infected. These protocols typically include sterilizing the access site, port, and VAD, and flushing the catheter with a flushing solution before use. Specifically, practice standards for VADs generally recommend performing a flushing procedure after catheter placement, before infusion, and before and after administration of medications, blood sampling, blood transfusion, and / or parenteral nutrition. Practice standards may also require that when not in use, the access site, port, and valve be capped with a disinfecting cap to prevent microorganisms from entering the site, port, or valve, and sterilizing the area that comes into contact with the access site, port, or valve of the VAD. A disinfecting cap is a disposable cap device that contains a quantity of cleaning or disinfecting solution for sterilizing portions of the port, site, and valve.

[0006] The access seat and the port can have various different types of male or female connectors for securing the seat or port to the VAD. Currently, practitioners often carry multiple types of caps so that they can cap different types of seats and ports, which can all be used for a particular patient. For example, caps for male and female needleless connectors and intravenous (IV) lines and hemodialysis lines typically use different connector designs and may require different caps. There may be a "male disinfection cap device" for disinfecting female threaded fluid Luer connectors of type ISO 594-2 and a "female disinfection cap device" for disinfecting male threaded fluid Luer connectors of type ISO 594-2.

[0007] Examples of some general caps suitable for male and female connectors are known. For example, U.S. Patent No. 10,871,246, titled "Universal connector or cap for male and female threaded fittings," discloses a cap that includes threaded protrusions capable of engaging male and female connectors, and this U.S. Patent is hereby incorporated by reference in its entirety. However, there is a need for a simpler cap design that can be manufactured inexpensively and efficiently. The universal cap of the present disclosure is configured to attach to both male and female medical connectors in a secure manner sufficient to prevent microbial intrusion. Additionally, the universal cap of the present disclosure is configured to be easily manufactured in a single molding process. Summary of the Invention

[0008] According to one aspect of the present disclosure, a cap configured to engage at least a first connector and a second connector of different types, the cap including a housing having an open first end, a second end, at least one sidewall extending between the first end and the second end, and at least one opening extending through the at least one sidewall. The cap further includes a flexible sleeve disposed within the housing, the flexible sleeve having a first end, a second end, and a sleeve sidewall extending between the first end and the second end. The cap further includes a lock connected to the housing, the lock configured to move through the at least one opening of the housing to press against the sleeve sidewall, which causes the sleeve sidewall to press directly or indirectly against a portion of the first connector or the second connector to secure the first connector or the second connector within the housing. The cap further includes an absorbent member disposed within the flexible sleeve, the absorbent member configured to hold a cleaning solution for cleaning and / or disinfecting the portion of the first connector or the second connector that engages with the cap.

[0009] According to an embodiment of the present invention, the first connector is a female connector and the second connector is a male connector.

[0010] According to an embodiment of the present invention, the cap is sized to receive a male connector and / or a female connector having different thread configurations and sizes.

[0011] According to an embodiment of the present invention, the cap is sized to receive a female connector having threads with a crest width of from about 0.3 mm to about 1.0 mm and a root width of from about 0.5 mm to 1.2 mm.

[0012] According to an embodiment of the present invention, the first connector includes a female Luer connector and the second connector includes a male Luer connector.

[0013] According to an embodiment of the present invention, the inner surface of the flexible sleeve is a cylindrical surface without threads or grooves.

[0014] According to an embodiment of the present invention, the absorbent member is configured to clean and / or disinfect the threaded surface of the first connector or the second connector.

[0015] According to an embodiment of the present invention, the lock is configured to be connected to the housing to hold the lock against the flexible sleeve, thereby fixing the first connector or the second connector in the housing.

[0016] According to an embodiment of the present invention, a first portion of the lock is rotatably connected to the housing such that the lock rotates about the first portion towards the flexible sleeve in a first direction, and wherein a second portion of the lock is connected to the housing to prevent the lock from rotating away from the flexible sleeve in a second direction.

[0017] According to an embodiment of the present invention, the housing and the lock include a rigid thermoplastic polymer having at least one of polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene.

[0018] According to an embodiment of the present invention, the housing further includes a tab, and wherein the lock is rotatably, slidably, and / or pivotally connected to the tab.

[0019] According to an embodiment of the present invention, the housing includes a plurality of ridges or ribs (for easier grasping of the housing) extending outwardly from an outer surface of the housing.

[0020] According to an embodiment of the present invention, the flexible sleeve includes a thermoplastic elastomer having at least one of silicone, polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene).

[0021] According to an embodiment of the present invention, the outer diameter of the flexible sleeve substantially matches the inner diameter of the housing.

[0022] According to an embodiment of the present invention, the first end of the sleeve includes an opening and a flange extending around the opening, and wherein the flange rests against the open first end of the housing.

[0023] According to an embodiment of the present invention, the lock deforms the sleeve radially inward to directly or indirectly contact the portion of the first connector or the second connector.

[0024] According to an embodiment of the present invention, the first end of the sleeve is open and the second end of the sleeve is closed.

[0025] According to an embodiment of the present invention, the inner diameter of the flexible sleeve is greater than the maximum outer diameter of the first connector or the second connector, such that the flexible sleeve does not impede the insertion of the first connector or the second connector into the housing.

[0026] According to an embodiment of the present invention, the housing further includes a tab.

[0027] According to an embodiment of the present invention, the lock is rotatably engaged to the tab such that the lock rotates relative to the tab to press against the flexible sleeve.

[0028] According to an embodiment of the present invention, the tab of the housing further includes a slot, and wherein a portion of the lock is inserted into the slot to hold the lock in contact with the flexible sleeve.

[0029] According to an embodiment of the present invention, the lock includes: a proximal end connected to the tab of the housing; a distal end opposite the proximal end; and a cam portion located between the proximal end and the distal end of the lock.

[0030] According to an embodiment of the present invention, the cam portion includes a concave inner surface and a convex outer surface, and wherein the rotation of the lock relative to the housing causes the convex outer surface of the cam portion to contact the flexible sleeve.

[0031] According to an embodiment of the present invention, the distal end of the lock includes a handle configured to be grasped by a user to rotate the lock towards the flexible sleeve.

[0032] According to an embodiment of the present invention, the proximal end of the lock includes a proximal post configured to be inserted into a hole in the tab of the housing, thereby forming a point of rotation for the lock to rotate relative to the housing.

[0033] According to an embodiment of the present invention, the distal end of the lock includes a distal post extending therefrom, the distal post configured to be inserted into a slot extending through the tab of the housing to hold the lock in a position where it presses against the flexible sleeve.

[0034] According to one embodiment of the present invention, by rotating the lock about a pivot point, the distal post is moved through the slot and the pressure against the flexible sleeve is increased.

[0035] According to one embodiment of the present invention, the slot includes a plurality of protrusions configured to engage the distal post to hold the lock in a selected position relative to the flexible sleeve.

[0036] According to one embodiment of the present invention, the lock applies a variable pressing force to the sleeve, and the pressing force increases proportionally as the rotation angle of the lock relative to the housing increases.

[0037] According to one embodiment of the present invention, the lock is connected to the housing in at least one of a slidable manner, a pivotable manner, or a rotatable manner.

[0038] According to one embodiment of the present invention, the pressing force of the lock on the flexible sleeve causes the first connector or the second connector to be held in a position within the flexible sleeve where the longitudinal axis of the connector is offset from the longitudinal axis of the housing of the cap.

[0039] According to one embodiment of the present invention, a seal is provided in the housing over the absorbent member to clean and disinfect the first connector or the second connector when the first connector or the second connector is inserted into the housing.

[0040] According to one embodiment of the present invention, the seal includes a non-porous foam, such as a closed-cell foam.

[0041] According to one embodiment of the present invention, the absorbent member includes a sponge.

[0042] According to one embodiment of the present invention, the absorbent member includes an open-cell foam, such as a porous foam having a thermoplastic elastomer.

[0043] According to one embodiment of the present invention, the insertion of the first connector or the second connector into the housing causes the absorbent member to be axially compressed.

[0044] According to one embodiment of the present invention, the axial compression of the absorbent member causes the cleaning solution of the absorbent member to contact the threads and surfaces of the first connector or the second connector.

[0045] According to one embodiment of the present invention, the cleaning solution is absorbed by the absorbent support.

[0046] According to one embodiment of the present invention, the cleaning solution includes isopropyl alcohol (IPA).

[0047] According to one embodiment of the present invention, the cleaning solution includes about 0.5% to about 3.5% chlorhexidine gluconate and about 70% IPA.

[0048] According to an embodiment of the present invention, a protective cover is located on the open first end of the housing.

[0049] According to an embodiment of the present invention, the protective cover is attached to the housing by heat sealing.

[0050] According to an embodiment of the present invention, a flange extends around the opening at the first end of the flexible sleeve and is positioned between the cover and the open first end of the housing.

[0051] According to another aspect of the disclosure, a method for attaching the aforementioned cap to a first connector or a second connector includes: inserting the distal end of the first connector or the second connector through the open first end of the housing and the first end of the flexible sleeve. The method further includes: applying axial pressure to the connector, causing the absorbent member to be axially compressed and the distal end of the connector to move further into the flexible sleeve; and moving a portion of the lock through at least one opening in at least one sidewall of the housing, thereby directly or indirectly squeezing the flexible sleeve against the connector to hold the connector within the housing.

[0052] According to an embodiment of the present invention, the method further includes: inserting the distal end of the first connector or the second connector through the open first end of the housing and the first end of the flexible sleeve, and applying axial pressure to the connector, causing the absorbent member to be axially compressed and the distal end of the connector to move further into the flexible sleeve; and moving a portion of the lock through at least one opening in at least one sidewall of the housing, thereby directly or indirectly squeezing the flexible sleeve against the connector to hold the connector within the housing.

[0053] According to an embodiment of the present invention, inserting the connector into the housing includes inserting the connector through the open first end of the housing and the first end of the flexible sleeve without rotating or spinning the connector relative to the flexible sleeve.

[0054] According to an embodiment of the present invention, the first connector is a female connector and the second connector is a male connector.

[0055] According to an embodiment of the present invention, the housing further includes a tab, and wherein the lock is rotatably engaged with the tab such that the lock rotates relative to the tab to squeeze against the flexible sleeve.

[0056] According to an embodiment of the present invention, the tab of the housing further includes a slot, and wherein a portion of the lock is inserted into the slot to hold the lock in contact with the flexible sleeve.

[0057] According to an embodiment of the present invention, the lock includes: a proximal end connected to the tab of the housing; a distal end opposite the proximal end; and a cam portion located between the proximal end and the distal end of the lock.

[0058] According to an embodiment of the present invention, the distal end of the lock includes a handle configured to be grasped by a user, and wherein the user grasps the handle to move the lock through at least one opening in at least one sidewall of the housing.

[0059] According to an embodiment of the present invention, the distal end of the lock includes a distal post extending therefrom, and the method further includes inserting the distal post of the lock into a slot of a tab to hold the lock in a position where it is squeezed against a flexible sleeve.

[0060] According to an embodiment of the present invention, the method further includes removing a protective cap located on a first open end of the housing before inserting the distal end of the first connector or the second connector through the first open end of the housing.

[0061] According to another aspect of the disclosure, a cap includes a housing having a first open end, a second end, at least one sidewall extending between the first end and the second end, at least one opening extending through the at least one sidewall, and a tab extending outwardly from the at least one sidewall of the housing. The tab includes a hole and a slot. The cap further includes a lock and a flexible sleeve disposed in the housing, the flexible sleeve having a first end, a second end, and a sleeve sidewall extending between the second end and the first end. The lock includes: (i) a proximal post inserted into the hole of the tab to provide a rotational engagement between the lock and the tab; and (ii) a distal post configured to be inserted into the slot of the tab to prevent rotation of the lock relative to the tab. The cap further includes an absorbent member disposed in the flexible sleeve, the absorbent member configured to hold a cleaning solution for cleaning and / or disinfecting a portion of the first connector or the second connector that engages the cap.

[0062] According to an embodiment of the present invention, the cap is configured to receive a connector, and wherein, in the case of inserting the connector into the housing, moving the lock in a first direction causes the lock to be squeezed against the flexible sleeve, which secures the connector to the housing.

[0063] According to an embodiment of the present invention, the cap is configured to receive different types of connectors, such as male connectors and female connectors.

[0064] According to an embodiment of the present invention, the cap is configured to receive connectors having different sizes and different thread configurations.

[0065] According to an embodiment of the present invention, the lock includes a proximal end having a proximal post, a distal end opposite the proximal end, and a cam portion located between the proximal end and the distal end of the lock.

[0066] According to an embodiment of the present invention, the cam portion includes a concave inner surface and a convex outer surface, and wherein rotation of the lock relative to the housing causes the convex outer surface of the cam portion to contact the flexible sleeve.

[0067] According to an embodiment of the present invention, the distal end of the lock includes a handle configured to be grasped by a user to rotate the lock towards the flexible sleeve.

[0068] According to an embodiment of the present invention, the slot includes a plurality of protrusions configured to engage the distal post to hold the lock in a selected position relative to the flexible sleeve. BRIEF DESCRIPTION OF THE DRAWINGS

[0069] FIG. 1A is a cross-sectional view of an exemplary male connector known in the prior art.

[0070] FIG. 1B is an example of a closed female connector including a diaphragm with a slit known in the prior art.

[0071] Figure 2A is a perspective view of a universal cap according to one aspect of the present disclosure, wherein the lock of the cap is in the open position.

[0072] Figure 2B is Figure 2A a perspective view of the cap of

[0073] Figure 2C is Figure 2A a perspective view of a cross-section of the cap of

[0074] Figure 3 is Figure 2A a perspective exploded view of the cap of

[0075] Figure 4A is Figure 2A a bottom view of the cap of

[0076] Figure 4B is Figure 2A a top view of the cap of

[0077] Figure 5A is Figure 2A a bottom view of the cap of

[0078] Figure 5B is Figure 2A a cross-sectional view of the cap of

[0079] Figure 6A is a cross-sectional view of the female connector and Figure 2A the cap before inserting the female connector into the cap.

[0080] Figure 6B is Figure 2A a cross-sectional view of the cap of

[0081] Figure 6C is Figure 2ACross-sectional view of the cap, with the male connector inserted into the cap.

[0082] Figure 7 is a flow chart showing a method for attaching a universal cap to a male connector and a female connector. Detailed Description

[0083] The following description is provided to enable a person skilled in the art to make and use the described embodiments contemplated for carrying out the invention. However, various modifications, equivalents, variations, and alternatives will still be apparent to a person skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the invention.

[0084] For the purposes of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal" and their derivatives shall relate to the orientation of the invention in the drawings. The term "proximal" refers to the part of the device or component that is grasped by the user or connected to another device or component. The term "distal" refers to the part of the device or component that is opposite the proximal part (i.e., the part that is farthest from the part grasped by the user or connected to another component). For example, for an implantable medical device such as a catheter, the proximal part may refer to the part of the catheter that remains outside the patient's body and is manipulated by the user. The distal part of the catheter may be the part inserted into the patient's blood vessel. For an object or component such as an elongate member, the proximal end may be the end connected to another object or component. The distal end of the elongate member is opposite the proximal end and may be freely unconnected to other objects or components. However, it should be understood that the invention may present alternative variations and sequences of steps, unless specifically stated to the contrary. It should also be understood that the specific devices and processes shown in the drawings and described in the following specification are merely exemplary embodiments of the invention. Accordingly, the specific dimensions and other physical characteristics related to the embodiments disclosed herein should not be considered restrictive.

[0085] The present disclosure relates to a cap 10 configured to connect to medical connectors 110, 112, such as access seats, ports, or valves for a VAD, to prevent the connectors, ports, or VAD from being contaminated by, for example, microorganisms, debris, or other contaminants. In some examples, the cap 10 may be configured to clean or disinfect a portion of the connectors 110, 112 or the port, ensuring that the connectors 110, 112 or the port remain sterile prior to use. The cap 10 may be configured to remain in place on the connectors 110, 112 or the port for at least seven days, which is the maximum recommended use time allowed by the sterile operating guidelines of many medical institutions.

[0086] The cap 10 is a universal cap, which means it is configured to engage or connect to medical connectors 110, 112 of different sizes, configurations, and / or types. For example, the cap 10 can be configured to engage or connect to both male connectors 110 and female connectors 112. As used herein, a "male connector" refers to a connector 110 that includes an elongated member (such as a tubular member or rod 114) configured to be inserted into a tube or opening having an inner diameter larger than the outermost diameter of the male connector 110. An exemplary male connector 110 is shown in FIG. 1A. In contrast, a "female connector" refers to a connector 112 that includes an opening or port 116 configured to receive an elongated member or tubular member of another object or device in order to connect the object or device to the female connector 112. The female connector 112 can include an elongated distal portion 108 having a cap or diaphragm 118 over the opening 116. An exemplary female connector 112 is shown in FIG. 1B, which includes a diaphragm 118 having a slit 120.

[0087] In some examples, the cap 10 is configured to engage different types of Luer connectors, such as both male Luer connectors 110 and female Luer connectors 112. For example, the cap 10 can be sized to receive a female Luer connector 112 having an outer diameter of about 7.0 mm to about 8.0 mm. The cap 10 can also be sized to receive a male Luer connector 110 having an outer diameter of about 8.0 mm to about 12.0 mm.

[0088] As used herein, a "Luer connector" refers to a connector that includes a tapered portion (i.e., a Luer taper) for establishing a friction engagement between the tapered rod 114 or elongated member of the male Luer connector 110 and a tapered cavity. For example, the male Luer connector 110 can include a tapered rod 114 or elongated member having a tapered outer surface. The female Luer connector 112 can include a tapered cavity configured to receive and engage the tapered rod 114 or elongated member to connect the male Luer connector 110 to the female Luer connector 112.

[0089] In some examples, the male connector 110 and the female connector 112 may include an engagement structure, such as a thread, for pulling the connectors 110, 112 to another connector or port. For example, as shown in FIG1A, the male Luer connector 110 may include an annular shield 122 extending around the tapered rod 114 or elongated member. The annular shield 122 may include threads 124 located on an inner surface 126 of the shield 122, which are configured to engage corresponding threads 128 on an outer surface 130 of the female Luer connector 112. As shown in FIG1B, the female Luer connector 112 includes threads 128 extending from the outer surface 130, which are positioned to engage the threads 124 on the inner surface 126 of the annular shield 122 of the male Luer connector 110. Rotating the female connector 112 relative to the male connector 110 causes the corresponding threads 124, 128 to engage, which draws the connectors 110, 112 together, causing the tapered shaft 114 or elongated member of the male luer connector 110 to move through the opening 116 of the female connector 112. In some examples, the female connector 112 can also include a vertical rib 132 near the proximal end of the female connector 112, which can be used to manipulate the female connector 112 to make it easier to rotate the female connector 112 relative to another connector or device.

[0090] There are many commercially available medical devices, such as seats, ports, and valves, that include different variations of male connectors 110 or female connectors 112, such as male and female Luer connectors. As described in further detail herein, the cap 10 of the present disclosure includes a flexible sleeve that can be constrained by a lock so as to engage and securely connect to connectors 110, 112 of different types and sizes. For example, the cap 10 can be configured to attach to both male and female Luer connectors 110, 112, such as male or female Luer-Lok® from Becton Dickinson and Company. TM Connectors. Cap 10 can also be configured to cover different connector designs, including but not limited to Becton Dickinson and Company's BD Q-Syte TM , BDMaxZero TM ,BD MaxPlus TM and SmartSite TMNeedleless connector. The cap 10 can also be configured to connect to male and / or female connectors of other manufacturers, including but not limited to MicroClave® connectors (ICU Medical Inc.) and Ultrasite® connectors (B.Braun Medical Inc.). In other examples, the cap 10 can be configured to connect to one or more of the following commercially available male connectors: Kendall 2001NP; BD MP5303-C; ICU Med 12664-28; RyMed RYM-5307HPU; B.Braun 470108; Baxter 2C8537; Kawasumi IV-0094; Zyno B2-70071-D; B.Braun 470124; Baxter 2C7462; and Smith’s Medical 536035.

[0091] Universal cap for male and female connectors

[0092] Figures 2A to 5B An example of the universal cap 10 is shown, which is configured to engage and / or connect to different types of connectors, such as any of the male connector 110 and female connector 112 described previously. Specifically, Figure 2A is a perspective view of the cap 10 showing the lock of the cap 10 in the open position. Figure 2B is a perspective view of the cap 10 where the lock is in the closed position. Figure 2C is a cross-sectional view of the cap 10 where the lock is in the open position. Figure 3 is an exploded view of the cap 10. Figure 4A and 4B are additional views showing the cap 10 with the lock in the open position. Figure 5A and 5B are additional views showing the cap 10 with the lock in the closed position. In some examples, the cap 10 can be provided as a single pre-packaged cap or cap assembly, such as Figures 2A to 5B the packaged cap shown. Additionally, as described in further detail herein, the cap 10 includes components for cleaning, scrubbing, and disinfecting the parts of the male connector 110 and female connector 112 inserted and installed into the cap 10, such as sponges, abrasive surfaces, and / or cleaning or disinfecting solutions.

[0093] As Figures 2A to 5B shown, the cap 10 includes a housing 12, which includes an open first end or top 14, a second end or bottom 16, and a sidewall 18 extending between the top 14 and the bottom 16. The housing 12 also includes an opening 20 that extends through the sidewall 18 of the housing 12. For example, as Figure 2A and 2BAs shown, the opening 20 can be a rectangular opening that is located between the top 14 and the bottom 16 of the housing 12. The rectangular opening 20 can have a long side that extends circumferentially along the housing 12 and a short side that extends axially (e.g., between the top 14 and the bottom 16 of the housing 12). As Figure 5B shown, the opening 20 can extend an angular distance of about 30 degrees to about 60 degrees (represented by the angle α in Figure 5B ). Other portions of the sidewall 18 of the housing 12 can be without openings.

[0094] The housing 12 can also include an extension or tab 22 that extends from the sidewall 18 of the housing 12. The tab 22 can be arranged to make it easier for a practitioner to grasp or manipulate the cap 10 when using the cap 10. For example, the practitioner can grasp the tab 22 when removing the packaging, lid, and other seals from the cap 10 before use. As further described herein, the tab 22 can include holes 24 and one or more slots 26 that are visible on the underside of the tab 22 (as shown in Figure 2A 、 2B 、4A, and 5A) for securing the lock 28 or locking mechanism of the cap 10 to the housing 12. For example, the lock 28 can be rotatably, slidably, and / or pivotally connected to the tab 22.

[0095] In some examples, the housing 12 also includes a protrusion that extends outwardly from the outer surface of the sidewall 18 of the housing 12, such as an axially extending rib or ridge 30. The axial ridge 30 can be arranged to increase the stiffness of the housing 12 compared to the case where the ridge 30 is absent. Additionally, the ridge 30 can make the housing 12 easier to grasp and manipulate, thereby improving the usability of the cap 10 and, for example, making it less likely for the practitioner to drop or mishandle the cap 10 during use.

[0096] In some examples, the housing 12 is a molded component formed by injection molding or other common molding processes. The housing 12 can be formed from a thermoplastic polymer material, such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene. In some examples, the housing 12 can be formed from a durable material, such as a material having a Shore D hardness value of less than or equal to 95 (Shore D). Alternatively, the housing 12 can be formed from a more flexible material, such as a material having a Shore A hardness value of less than or equal to 130 (Shore A).

[0097] The cap 10 further includes a flexible sleeve 32 disposed within the housing 12. The flexible sleeve is sized to receive the connectors 110, 112 and is configured to squeeze or constrict against the connectors 110, 112 to secure the connectors 110, 112 within the housing 12. In some examples, the inner diameter of the flexible sleeve 32 can be greater than the maximum outer diameter of the distal portions of the connectors 110, 112 such that the flexible sleeve 32 does not restrict the insertion of the connectors 110, 112 into the housing 12 or otherwise contact the connectors 110, 112 until the flexible sleeve 32 is constricted against the connectors 110, 112 by the lock 28.

[0098] The flexible sleeve 32 can include a first or top end 34, a second or bottom end 36, and a sleeve sidewall 38 extending between the top end 34 and the bottom end 36. The flexible sleeve 32 can include or can be formed of a flexible material that can be radially inwardly pressed to constrict against the connectors 110, 112. For example, the flexible sleeve 32 can be made of silicone or other thermoplastic elastomers such as polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene).

[0099] In some examples, the flexible sleeve 32 is a tubular body having a closed bottom 36 configured to rest against the closed bottom 16 of the housing 12 and an open top 34. The outer diameter of the sleeve sidewall 32 can match (e.g., can be equal to or slightly smaller, e.g., about 5% smaller) the inner diameter of the housing 12 such that the flexible sleeve 32 fits within the housing 12. The flexible sleeve 32 can define a cylindrical interior or cavity that receives the distal portions of the connectors 110, 112. Additionally, the sleeve sidewall 38 can be cylindrical, having a cylindrical inner surface and / or a cylindrical outer surface. The inner surface and / or the outer surface of the sleeve sidewall 38 can be without threads or grooves. Instead, as described above, the connectors 110, 112 are secured within the housing 12 because the flexible sleeve 32 is constricted around the connectors 110, 112 by the lock 28. More specifically, as described in further detail herein, the connectors 110, 112 are secured to the flexible sleeve 32 by a radially inward pressure exerted by the lock 28 against the flexible sleeve 32. The flexible sleeve 32 is not connected to the connectors 110, 112 by an engagement between the threads of the connectors 110, 112 and corresponding threads of the flexible sleeve 32 or the housing 12.

[0100] In some examples, the top end 34 of the flexible sleeve 32 includes an annular flange 40 that extends radially outward from an opening at the top end 34 of the flexible sleeve 32. For example, as Figure 2C shown, the annular flange 40 rests against the open top 14 of the housing 12, creating a space between the open top 14 of the housing 12 and a package (e.g., protective cover 42) disposed on the open top 14 of the housing 12.

[0101] The cap 10 further includes a lock 28 connected to the housing 12, the lock being configured to move through an opening 20 in the side wall 18 of the housing 12 to press against the sleeve side wall 38. The lock 28 can engage (e.g., rotatably, slidably, and / or pivotally engage) or connect to a tab 22 of the housing 12, as Figure 2A and 2B most clearly shown. The lock 28 can be configured to move from an open position (as Figure 2A shown) to a closed position (as Figure 2B shown), in the closed position, the lock 28 presses against the flexible sleeve 32. In some examples, the lock 28 applies a variable pressing force to the flexible sleeve 32, and the pressing force increases proportionally with the rotation angle of the lock 28 relative to the tab 22 of the housing 12. Thus, the farther the lock 28 rotates in a first direction (as Figure 4A and 4B shown by the arrow A1), the tighter the connectors 110, 112 are held within the housing 12.

[0102] In some examples, the lock 28 is configured to be grasped and manipulated by a practitioner to move the lock 28 from an open position ( Figure 2A ) to a closed position ( Figure 2B ). For example, the practitioner can grasp and press the lock 28, causing the lock 28 to rotate, slide, and / or pivot toward the flexible sleeve 32. The pressure exerted by the lock 28 on the sleeve side wall 38 of the flexible sleeve 32 causes the sleeve side wall 38 to press directly or indirectly against a portion of the connector (e.g., the male connector 110 or the female connector 112) to fix the connectors 110, 112 within the housing 12. In some examples, the inner surface of the sleeve side wall 38 directly contacts and presses against the connectors 110, 112 to fix the connectors 110, 112 within the housing 12. In other examples, the sleeve side wall 38 can indirectly contact the connectors 110, 112 through one or more intermediate structures. For example, the sleeve side wall 38 can contact and press against an intermediate sleeve, layer, tube, component, or other structure to apply the pressure from the lock 28 to the connectors 110, 112 through the sleeve side wall 38.

[0103] For example, as Figure 2B shown, the lock 28 applies a pressing force only to one side of the flexible sleeve 32. Thus, the pressing force of the lock 28 against the flexible sleeve 32 can cause the connectors 110, 112 to be held within the flexible sleeve 32 in a non - concentric orientation. Specifically, the female connector 112 can be held at a position within the housing 12 where the longitudinal axis X2 of the female connector 112 (shown in Figure 6A and 6B ) is offset from the longitudinal axis X1 of the housing 12 of the cap 10 (shown in Figure 2C , 6Aas shown in FIGS. 6A and 6B).

[0104] In some examples, a portion of the lock 28 may be configured to connect to the housing 12 to hold the lock 28 against the flexible sleeve 32 (i.e., to prevent the lock 28 from moving away from the flexible sleeve 32 until the lock 28 is released by a practitioner). For example, a first portion of the lock 28 (such as the proximal post 46) may be rotatably connected to the housing 12 such that the lock 28 rotates about the first portion (e.g., about the proximal post 46) toward the flexible sleeve 32 in a first direction (shown by the arrow A1 in FIGS. Figure 4A and 4B ). Additionally, a second portion of the lock 28 (such as the distal post 48) may be connected to the housing 12 to prevent the lock 28 from rotating away from the flexible sleeve 32 in a second direction (shown by the arrow A2 in FIGS. Figure 5A and 5B ).

[0105] In some examples, the lock 28 is a molded component formed of the same or a similar material as the housing 12. For example, the lock 28 may be formed of a thermoplastic polymer material such as polyester, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, or acrylonitrile butadiene styrene. Additionally, the lock 28 may include a proximal end 50 that includes the proximal post 46 that connects to the tab 22 of the housing 12. For example, the proximal post 46 of the lock 28 may be inserted into the hole 24 of the tab 22 such that the lock 28 rotates about the proximal post 46 toward or away from the flexible sleeve 32. The lock 28 may also include a distal end 52 that includes the distal post 48 opposite the proximal end 50 and a cam portion 54 located between the proximal end 50 and the distal end 52 of the lock 28. The cam portion 54 may include a concave inner surface 56 and a convex outer surface 58. Rotation of the lock 28 relative to the tab 22 (in the first direction shown by the arrow A1 in FIGS. Figure 4A and 4B ) causes the convex outer surface 58 of the cam portion 54 to contact the flexible sleeve 32. Desirably, a majority of the area of the convex outer surface 58 (e.g., at least 25%, 50%, or 75% of the total area of the convex outer surface 58) contacts the flexible sleeve 32, thereby distributing the locking force from the lock 28 over a majority of the outer surface of the sleeve sidewall 38. Accordingly, the pressing force of the sleeve sidewall 32 against the connectors 110, 112 is distributed over a majority of the outer surfaces of the connectors 110, 112. By distributing this pressing force over a majority of the area of the outer surfaces of the connectors 110, 112, a secure connection is formed between the connectors 110, 112 and the cap 10 without crushing or deforming any particular portion or component of the connectors 110, 112.

[0106] The distal post 48 of the lock 28 can be configured to be inserted into the slot 26 of the tab 22 to hold the lock 28 in a position pressed against the flexible sleeve 32. Specifically, a practitioner can rotate the lock 28 toward the flexible sleeve 32, causing the cam portion 54 of the lock 28 to press against the flexible sleeve 32. Once the lock 28 applies sufficient pressure against the flexible sleeve 32 to secure the connectors 110, 112 to the cap 10, the practitioner can push the lock 28 in an upward direction, which inserts the distal post 48 into the slot 26. By inserting the distal post 48 into the slot 26, the lock 28 is fixed in place, preventing the lock 28 from rotating away from the flexible sleeve 32, which secures the connectors 110, 112 in the housing 12. In some examples, the distal post 48 can slide through the slot 26 in a first direction to fasten the lock 28 against the flexible sleeve 32. In such cases, the slot 26 can include a protrusion that prevents the distal post 48 from moving through the slot 26 in a second direction to loosen the lock 28. To disengage the lock 28, the practitioner removes the distal post 48 from the slot 26, thereby releasing the lock from engagement with the flexible sleeve 32.

[0107] In other examples, as shown, the slot 26 includes protrusions that form segments or circular holes or openings. The size of each segment or circular opening can be designed to receive the distal post 48, preventing the distal post 48 from sliding through the slot 26 in any direction (i.e., preventing the distal post 48 from sliding through the slot 26 in a first direction to fasten the lock 28 or in a second direction to loosen the lock 28). In such an example, with the distal post 48 outside the slot 26, the practitioner applies pressure to the lock 28, causing the lock to press against the flexible sleeve 32. Once the lock 28 is tight enough, the practitioner moves the distal post 48 into the slot 26 to hold the lock 28 in place against the flexible sleeve 32. The practitioner releases the lock 28 by removing the distal post 48 from the slot 26.

[0108] In some examples, the distal end 52 of the lock 28 further includes a handle 60 that is configured to be grasped by a practitioner to rotate the lock 28 toward the flexible sleeve 32. For example, the handle 60 can include one or more flat pressing surfaces that a practitioner can manipulate to move the lock 28 from an open position to a closed position. The handle 60 can be designed to be large enough for a practitioner to easily grasp and manipulate, e.g., pressing against the handle 60 with one finger, pressing against the handle 60 with two fingers, pressing against the handle 60 with one thumb, and / or grasping the handle 60 between a finger and a thumb.

[0109] The cap 10 further includes an absorber, absorbent member, or support structure (referred to herein as absorbent member 62) for cleaning and disinfecting the portions of the male connector 110 and female connector 112 that are inserted into the cap 10, such as the threaded surfaces of the connectors 110, 112 (e.g., the roots and crests of the threads 124, 128). In particular, the absorbent member 62 may be configured to clean and disinfect the surface of the stem 114, as well as the inner surface 126 and threads 124 of the annular shroud 122 of the male connector 110. The absorbent member 62 may also be configured to clean and disinfect the distal portion 108 of the female connector 112, the opening or port 116, and portions of the diaphragm 118.

[0110] As Figure 2C shown, the absorbent member 62 may be disposed and retained within a cylindrical interior space or cavity defined by the flexible sleeve 32. For example, the absorbent member 62 may be held in place within the flexible sleeve 32 by conventional adhesives or mechanical fasteners. In other examples, the absorbent member 62 may be held in place within the flexible sleeve 32 by friction between the inner surface of the sleeve sidewall 38 and the outer surface of the absorbent member 62.

[0111] In some examples, the absorbent member 62 comprises or is formed from an absorbent material capable of absorbing a cleaning or disinfecting solution for cleaning and / or disinfecting portions of the male connector 110 and female connector 112. Additionally, the absorbent member 62 may be configured to be axially compressed as the distal portions of the connectors 110, 112 are inserted into the housing 12 and flexible sleeve 32. The axial compression of the absorbent member 62 may cause the cleaning solution of the absorbent member 62 to flow away from the absorbent member 62 and contact the threads and other surfaces of the connectors 110, 112 to clean and disinfect portions of the connectors 110, 112.

[0112] In some examples, the absorbent member 62 may include a thermoplastic elastomer, such as polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene). The absorbent member 62 may also include a porous foam (e.g., open-cell foam) or sponge capable of absorbing a cleaning or disinfecting solution, such as a foam or sponge containing polyurethane. In other examples, the foam material may be Plastazote® foam, which is an engineered polymer foam manufactured by Zotefoams PCL.

[0113] In some examples, the height of the absorbent member 62 and / or the amount of cleaning or disinfecting solution contained therein can be optimized for use with both the short connectors and the tall connectors 110, 112. As used herein, a "short connector" refers to connectors 110, 112 that do not insert very far into the cap 10. In contrast, a "tall connector" refers to a connector that inserts a relatively large distance into the cap 10 such that the distal end of the connectors 110, 112 is near the bottom 36 of the flexible sleeve 32. In particular, the height of the absorbent member 62 and the amount of cleaning or disinfecting solution contained therein should be large enough so that when the cap 10 is attached to the short connector, sufficient cleaning solution is released from the absorbent member 62 to disinfect the surface of the short connector. However, the height of the absorbent member 62 and the amount of cleaning solution may be limited to some extent so that when the cap 10 is attached to the taller connector (which axially compresses the absorbent member 62 a significant amount), no liquid enters the lumen of the connectors 110, 112.

[0114] The absorbent member 62 can be provided (i.e., pre-impregnated) with a cleaning or disinfecting solution. For example, the cleaning or disinfecting solution can be an antimicrobial, antifungal, antibacterial, or antiviral solution that cleans and sterilizes the surface of the connectors 110, 112. In some examples, the cleaning solution can be isopropyl alcohol (IPA), e.g., about 70% IPA. In other examples, the cleaning solution can be a combination of about 0.5% to about 3.5% chlorhexidine gluconate and about 70% IPA. The chlorhexidine composition may be beneficial because it has a slower evaporation rate than IPA and thus provides a more persistent disinfection activity after the cap 10 is removed from the connectors 110, 112 and before the VAD is connected to the seat, port, or valve.

[0115] In some examples, the cap 10 further includes a seal 64 located on the absorbent member 62 (e.g., positioned between the top of the absorbent member 62 and the top 34 of the flexible sleeve 32). The seal 64 can prevent fluid (e.g., the cleaning or disinfecting solution in the cap 10) from flowing into the lumen of the male luer connector 110 when the male luer connector 110 is inserted into the cap 10. In some examples, the seal 64 can be made of a thermoplastic elastomer that includes, for example, an elastomeric closed-cell foam. The seal 64 can also include an abrasive material that is capable of scrubbing or mechanically removing objects (e.g., microorganisms and debris) from the surface of the connectors 110, 112 while restricting the intrusion of the cleaning or disinfecting solution into portions of the connectors 110, 112.

[0116] In some examples, the cap 10 can further include a removable and / or disposable protective cap 42 that is located on the open top 14 of the housing 12 and / or the top 34 of the flexible sleeve 32. For example, as Figure 2CAs shown, the protective cap 42 can extend over the top 34 of the flexible sleeve 32 and the flange 40, and can adhere to a portion of the top 14 of the housing 12. A portion of the cap 42 can also extend over and / or can adhere to the top surface of the tab 22 of the housing 12.

[0117] The protective cap 42 is provided to protect the components and parts of the cap 10, such as the housing 12, the flexible sleeve 32, the seal 64, and the absorbent member 62, during transportation and storage to prevent contamination and to prevent the evaporation of cleaning or disinfecting solutions before use. The protective cap 42 can include a sheet, such as a polymer film, having an adhesive on a first side of the sheet for removably mounting the protective cap 42 to the open top of the housing 12. Alternatively, the protective cap 42 can be removably mounted to the open top 14 of the housing 12 by heat sealing. The protective cap 42 can be made of a material that is air-impermeable or substantially impermeable, such that the cleaning or disinfecting solution on the absorbent member 62 does not evaporate or dry. Thus, the protective cap 42 can increase the shelf life of the cap 10 and prevent microorganisms and other debris from accumulating in the cap 10 before use.

[0118] Method of attaching a connector to a cap

[0119] As previously described, the cap 10 of the present disclosure is a universal cap 10 configured to connect to various types and sizes of male connectors 110 and female connectors 112. For example, Figure 6A and 6B shows the cap 10 connected to the female connector 112. Figure 6C shows the cap 10 connected to the male connector 110. Figure 7 is a flow chart showing a method for connecting the universal cap 10 to the male connector 110 and the female connector 112 and / or disconnecting the universal cap from the male and female connectors.

[0120] As Figure 7 shown, at step 210, in order to connect the cap 10 to the male connector 110 or the female connector 112, the practitioner first removes any packaging from the cap 10 and removes the protective cap 42 from the open top 14 of the housing 12.

[0121] At steps 212a, 212b, once the packaging and the protective cap 42 are removed, the practitioner moves the connectors 110, 112 towards the open top 14 of the housing 12. For example, for the female connector 112 (shown at step 212a), the practitioner moves the female connector 112 towards the housing 12, as Figure 6AAs shown by arrow A3 in, the diaphragm 118 of the female connector 112 is caused to contact the seal 64 of the cap 10. Continuing to move the female connector 112 into the housing 112 enables the outer surface 130 and threads 128 of the tubular distal portion 108 of the female connector 112 to contact the seal 64. As previously described, the contact between the ground surface of the seal 64 and the surface of the female connector 112 can mechanically remove particles (e.g., microorganisms and other debris) from the surface of the female connector 112, which contributes to the cleaning effect provided by the cap 10.

[0122] For the male connector 110, as shown in step 212b, the practitioner moves the male connector 110 in the direction of arrow A4 ( Figure 6C as shown) toward the open top 14 of the housing 12, causing the stem 114 of the male connector 110 to be partially inserted into the housing 12 and bringing the distal end of the stem 114 into contact with the seal 64. Continuing to move the male connector 110 into the housing 12 also brings the distal end of the annular shroud 122 into contact with the seal 64. As previously described, the contact between the surface of the male connector 110 and the seal 64 can mechanically remove particles (e.g., microorganisms and other debris) from the male connector 110.

[0123] Continuing to apply axial pressure to the connectors 110, 112 causes the distal portions of the connectors 110, 112 to be further inserted into the housing 12 and the flexible sleeve 32, thereby axially compressing the absorbent member 62. Compression of the absorbent member 62 releases a cleaning or disinfecting solution, resulting in contact of the cleaning or disinfecting solution with portions of the connectors 110, 112. In particular, the cleaning solution can contact and disinfect the surface of the stem 114 and the annular shroud 122 of the male connector 110. When the female connector 112 is inserted into the cap 10, the cleaning solution can contact and disinfect portions of the female connector 112, including the diaphragm 118 and the outer surface 130 and threads 128 of the tubular distal portion 108 of the female connector 112.

[0124] Once a sufficient amount of the distal portions of the connectors 110, 112 are seated in the flexible sleeve 32 of the cap 10, the practitioner can use the lock 28 to secure the cap 10 to the connectors 110, 112. For example, as Figure 6C shown, the male connector 110 can be inserted into the housing 12 such that the distal end of the annular shroud 122 is positioned beyond the opening 20 in the sidewall 18 of the housing 12. Thus, when the lock 28 is closed, the flexible sleeve 32 contacts the sidewall of the shroud 122, as Figure 6C shown. As Figure 6B shown, the female connector 112 can be inserted far enough into the housing 23 such that the tubular distal portion 108 of the female connector 112 is positioned past the opening 20 in the sidewall 18 of the housing 12. Thus, when the lock 28 is closed, the flexible sleeve 32 is pressed against the widest part of the female connector 112, asFigure 6B as shown

[0125] More particularly, to engage the lock 28, at step 214, the practitioner first presses the lock 28 in a first direction (as shown by arrow A1 in Figure 4A and 4B ) to cause the convex outer surface 58 of the cam portion 54 to move through the opening 20 in the side wall 18 toward the flexible sleeve 32. The convex outer surface 58 contacts the flexible sleeve 32, causing the sleeve 32 to deform radially inwardly, which causes the flexible sleeve 32 to press against the connectors 110, 112. The practitioner continues to apply pressure to the lock 28 until the lock 28 is tight enough to secure the connectors 110, 112 in the cap 10.

[0126] At step 216, once the lock 28 is tight enough, the practitioner can slide the lock 28 in an upward direction to insert the distal post 48 of the lock 28 into the slot 26 of the tab 22 of the housing 12. As previously described, by inserting the distal post 48 into the slot 26, the lock 28 is secured in the closed position, preventing the lock 28 from loosening until the distal post 48 is removed from the slot 26.

[0127] At step 218, to remove the cap 10 from the connectors 110, 112, the practitioner first releases the lock 28 by removing the distal post 48 from the slot 26 and rotating the lock 28 in a second direction (as shown by arrow A2 in Figure 5A and 5B ) away from the flexible sleeve 32.

[0128] At step 220, once the lock 28 is released, the practitioner grasps the housing 12 of the cap 10 with one hand and the connectors 110, 112 with the other hand. Then, the practitioner pulls the connectors 110, 112 away from the cap 10 to remove the connectors 110, 112 from the cap 10. As previously described, the inner surface of the flexible sleeve 32 does not include threads. Thus, the practitioner does not need to rotate or turn the connectors 110, 112 relative to the cap 10 to remove the connectors 110, 112 from the cap 10. Instead, once the lock 28 is released, the practitioner only needs to axially pull the connectors 110, 112 away from the cap 10 to remove the cap 10. Once removed, the cap 10 can be discarded as it is typically a single-use product.

[0129] Once the connectors 110, 112 are completely removed from the housing 12, at step 222, the connectors 110, 112 can be connected to the VAD. For example, the connectors 110, 112 can be attached to or inserted into a seat, port, or valve of the VAD, thereby forming a needleless fluid-tight connection between the connectors 110, 112 and the flow path, channel, or lumen of the VAD.

[0130] Although examples of the universal cap 10 of the present disclosure and methods of using it are shown in the accompanying drawings and described in detail above, other examples will be apparent and readily manufacturable to those skilled in the art without departing from the scope and spirit of the invention. Accordingly, the foregoing description is intended to be illustrative and not restrictive. The invention described herein is defined by the appended claims, and all changes that fall within the meaning and equivalents of the claims will be embraced within their scope.

Claims

1. A cap configured to engage at least a first connector and a second connector of different types, the cap comprising: a housing including an open first end, a second end, at least one sidewall extending between the first end and the second end, and at least one opening extending through the at least one sidewall; a flexible sleeve disposed within the housing, the flexible sleeve including a first end, a second end, and a sleeve sidewall extending between the first end and the second end of the flexible sleeve; a lock connected to the housing, the lock configured to move through the at least one opening of the housing to press against the sleeve sidewall, which causes the sleeve sidewall to press directly or indirectly against a portion of the first connector or the second connector to secure the first connector or the second connector within the housing; and an absorbent member disposed within the flexible sleeve, the absorbent member configured to hold a cleaning solution for cleaning and / or disinfecting a portion of the first connector or the second connector that engages with the cap.

2. The cap according to claim 1, wherein, The first connector is a female connector and the second connector is a male connector.

3. The cap according to claim 1, wherein, The inner surface of the flexible sleeve is a cylindrical surface without threads or grooves.

4. The cap according to claim 1, wherein A removable connection between the lock and the housing holds the lock against the flexible sleeve, thereby securing the first connector or the second connector within the housing.

5. The cap according to claim 1, wherein, The flexible sleeve includes a thermoplastic elastomer including at least one of silicone, polypropylene, polyethylene, or synthetic or natural rubber (e.g., isoprene).

6. The cap according to claim 1, wherein, The first end of the flexible sleeve includes an opening and a flange, the flange extending around the opening of the first end of the flexible sleeve, and wherein the flange rests against the open first end of the housing.

7. The cap according to claim 1, wherein, The lock causes the flexible sleeve to deform radially inward to directly or indirectly contact the portion of the first connector or the second connector.

8. The cap according to claim 1, wherein, The housing further includes a tab extending from the at least one sidewall of the housing, and wherein the lock is rotatably engaged to the tab such that the lock rotates relative to the tab to press against the flexible sleeve.

9. The cap according to claim 8, wherein, The tab of the housing further includes a slot, and wherein a portion of the lock is inserted into the slot to hold the lock in contact with the flexible sleeve.

10. The cap according to claim 9, wherein, The lock includes a proximal end connected to the tab of the housing, a distal end opposite the proximal end, and a cam portion located between the proximal end and the distal end of the lock.

11. The cap according to claim 10, wherein, The cam portion includes a concave inner surface and a convex outer surface, and wherein rotation of the lock relative to the housing causes the convex outer surface of the cam portion to contact the flexible sleeve.

12. The cap according to claim 10, wherein, The distal end of the lock includes a handle configured to be grasped by a user to rotate the lock toward the flexible sleeve.

13. The cap according to claim 10, wherein, The proximal end of the lock includes a proximal post configured to be inserted into a hole in the tab of the housing, thereby forming a pivot point for rotation of the lock relative to the housing, and the distal end of the lock includes a distal post configured to be inserted into a slot in the tab of the housing to hold the lock in a position pressed against a flexible sleeve.

14. The cap according to claim 13, wherein, The slot includes a plurality of protrusions configured to engage the distal post to hold the lock in place relative to the flexible sleeve.

15. The cap according to claim 1, wherein The pressing force of the lock against the flexible sleeve causes the first connector or the second connector to be held in a position within the flexible sleeve where the longitudinal axis of the connector is offset from the longitudinal axis of the housing of the cap.

16. The cap according to claim 1, wherein, The cap further includes a seal disposed in the housing on the absorbent member to clean and disinfect the first connector or the second connector when the first connector or the second connector is inserted into the housing.

17. The cap according to claim 1, wherein, The absorbent member includes open-cell foam that includes a thermoplastic elastomer, and the cap further includes the cleaning solution absorbed by the absorbent support, wherein the cleaning solution includes isopropyl alcohol (IPA).

18. The cap according to claim 1, wherein, The cap further includes a protective cover on the open first end of the housing.

19. A method for attaching the cap according to claim 1 to a first connector or a second connector, the method comprising: inserting a distal end of the first connector or the second connector through the open first end of the housing and the first end of the flexible sleeve; applying an axial pressure to the connector, causing the absorbent member to axially compress the distal end of the connector and move the distal end of the connector further into the flexible sleeve; and moving a portion of the lock through the at least one opening in the at least one sidewall of the housing, thereby pressing the flexible sleeve directly or indirectly against the connector to hold the connector in the housing.

20. A cap, comprising: a housing including an open first end, a second end, at least one sidewall extending between the first end and the second end, at least one opening extending through the at least one sidewall, and a tab extending outwardly from the at least one sidewall of the housing, the tab including a hole and a slot; a flexible sleeve disposed in the housing, the flexible sleeve including a first end, a second end, and a sleeve sidewall extending between the first end and the second end of the flexible sleeve; a lock including: (i) a proximal post inserted into the hole in the tab, the proximal post providing a pivot joint between the lock and the tab; and (ii) a distal post configured to be inserted into the slot in the tab to prevent rotation of the lock relative to the tab; and an absorbent member disposed in the flexible sleeve, the absorbent member configured to receive a cleaning solution for cleaning and / or disinfecting a portion of the first connector or the second connector that engages the cap.

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